On Nov. 16, 2007, the U.S. Food and Drug Administration (FDA) announced that it had seized 12,682 applicator tubes of a product called Age Intervention Eyelash, worth approximately $2 million. The FDA, in its press release, alleges that the distributor was promoting the product’s use to increase eyelash growth, i.e. a drug use, and the FDA had not approved that use for this cosmetic product. This seizure is one of several enforcement actions or warnings issued by the agency in 2007 to companies for making unapproved drug claims on cosmetic-type products. Typically, these claims arise from representations of a product’s ability to provide a therapeutic or prophylactic benefit—claims usually found on the product labeling or on other promotional materials, including distributor Web sites. Once the line is crossed and a cosmetic is promoted as providing therapeutic or prophylactic uses or benefits, that product triggers FDA regulations governing drugs or products containing drugs. If those promoted uses or benefits were not pre-authorized by the FDA, then they are considered false and misleading, and the product is deemed misbranded. As the FDA’s recent actions suggest, the cost of noncompliance is high.

What’s a Cosmetic? What’s a Drug?Discussions related to labeling issues begin with an understanding of the legal definitions of “cosmetic” and of “drug.” A “cosmetic” is an article intended to be applied to the human body for “cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.” Products such as shampoos, perfumes and makeup fit this definition; however, not all products meeting this definition are cosmetics. Consider soap. Certain soap products, consisting primarily of an alkali salt of fatty acid and that do not make use claims other than for cleansing the human body, are not regulated as cosmetics.

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A “drug” is defined in the Food, Drug and Cosmetic (FD&C) Act as an article “(A) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease ... and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Before a new drug can be marketed legally, it must be approved by the FDA as safe and effective.But certain cosmetics satisfy both definitions. A product that is intended for use as a cosmetic but that is also intended for use to prevent or treat a disease or to affect the structure or function of the human body is regulated as a drug and as a cosmetic. The question to ask is whether the cosmetic product can exert a physical as well as a physiological effect on the user. If it can, then likely the cosmetic product is subject to both drug and cosmetic regulations. Toothpaste containing fluoride and shampoos containing an antidandruff treatment are two such examples.

A cosmetic’s intended use plays a key role in determining whether that product triggers the drug regulations. Intended use can be ascertained by reviewing claims on labels, promotional materials and Web sites. Consumer expectation and perception of a product’s intended use goes toward establishing that concept.

This threshold determination is important if a company intends to market a cosmetic in a way that touts certain uses or benefits that could fall within the drug definition. Cosmetics are not subject to premarket approval by the FDA. Premarket approval is the process where the FDA requires scientific review to ensure the safety and effectiveness of products it oversees. Drugs, on the other hand, are subject to FDA approval, either through the premarket approval process or because the FDA currently recognizes certain drugs or drug ingredients as safe and effective and publishes this recognition in monographs. These monographs identify how certain nonprescription drugs can be used without further premarket approval and what ingredients may be used to make them.

For a company to allege that its cosmetic product provides a benefit or use that meets the definition of a drug, that company must have either done the necessary premarket review with the FDA, or the product or ingredient thereof must be covered by an existing FDA monograph and used in a pre-approved way. Absent that, any representations of a cosmetic product as having an intended use for preventing or treating a disease, or affecting the structure or function of the human body, would be considered an unapproved and misbranded drug.

Labels on Cosmetics and Cosmetic/Drug Combination ProductsNot only must distributors of cosmetics be concerned with whether representations being made on their labeling implicates a drug use, but if in fact the product is a cosmetic/drug combination, then the representation on the actual label differs slightly from that for a pure cosmetic. Both pure cosmetics and cosmetic/drug combinations distributed in the U.S. must comply with the labeling requirements promulgated by the FDA, under the authority of the FD&C Act and the Fair Packaging and Labeling (FP&L) Act. These regulations require that key product information be conveyed to the consumer. The required information and placement thereof is dependent upon several factors, including whether the product is sold in retail packaging apart from the actual container holding the product and whether the product is a cosmetic/drug combination requiring the disclosure of additional information.

For both classes of products, the label on the outer packaging must convey much information. The name and street address (unless it is listed in the phone book) of the firm marketing the product must be stated on the information panel of the label. If the distributor is not the manufacturer or packer, then the label must state “Manufactured for” or “Distributed by.” The outermost label must contain directions for safe use and any warning statement necessary or appropriate to prevent a health hazard associated with the product.

The ingredient declaration is also found on this label. All cosmetics sold at retail for personal use must have an ingredient declaration. This list—which appears on the information panel of the package or on a firmly affixed tag, tape or card—must declare ingredients by the names established or adopted by regulation, in descending order of predominance. Color additives and ingredients that constitute 1% or less may be declared in any order. Ingredients exempted by the FDA from public disclosure may be stated as “and other ingredients.”

The label on the outer container must also state the product name, identify the commodity (in terms of the common or usual name—it can be an illustration or it can be a fanciful name if the nature of the cosmetic is obvious) and set out the accurate net quantity of the cosmetic(s) in the package.

The label requirements for the product’s actual container differ slightly from those of the outer packaging. This label must contain the same information as found on the outer packaging with the exception of the ingredient declaration. That being said, if the outer container is removed so that the product’s actual container becomes, in effect, the outer packaging, then the labeling information required on the outer packaging is now required on the actual container.

When a cosmetic contains a drug, the outer label is structured differently. In this situation, drugs must be identified (and done so first) as an “active ingredient,” separate from the other cosmetic ingredients. Also, any type of alcohol is to be listed first as an active ingredient. Cosmetic ingredients would then be listed thereafter as “cosmetic ingredients.”

A last point on labeling is worth stressing, and that is the devil is in the details. The regulations require that the necessary information be displayed in certain panels using certain font sizes set out in a conspicuous way. Issues involving U.S. country of origin marking also arise for imported merchandise, and this is a topic unto itself. In short, care must be taken to make sure that all regulatory requirements covering labels, labeling and origin marking are satisfied in a legally compliant way.

Final ThoughtsGiven the degree of regulations involved on what can be said regarding the benefits of using a particular cosmetic and what has to be stated on labeling to advise purchasers of key information, a periodic review of all such representations is strongly recommended. Check promotional materials and Web sites for exaggerated copy suggesting physical improvements to the human body if a particular product is used. Review product labels to make sure that required information is present and in the proper place on the products. Educate employees to understand why labeling content and how it is presented can impact a company’s compliance status. This simple exercise can catch problems before they arise and before a company finds itself on the wrong side of a seizure notice.